Quality Assurance Associate

ACTalent; Haltom City (TX); In loco; USD 33.000 - 39.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Descrizione del lavoro

ACTalent is seeking a Quality Assurance Specialist to act as a technical resource across Operations and Quality Assurance. You will analyze processes against ISO standards and 21 CFR 820, drive CAPA actions, manage complaint handling, and ensure procedures remain clear, compliant, and up-to-date in a medical device production environment. The role emphasizes cross-functional teamwork, regulatory alignment, and continuous improvement.

Competenze

• Quality assurance or Documentation Control preferably 13 years in quality assurance or operations.
• Background in QA, with additional QC experience considered beneficial.
• Experience in medical products, medical device, pharmaceutical, or disposable product manufacturing environments a plus.
• Practical experience with CAPA processes, including corrective action plans and follow-through.
• Technical writing skills for clear, structured reporting of investigations and preparation of compliance documentation.
• Ability to validate and refine work instructions and procedures to ensure clarity and regulatory alignment.
• Understanding of manufacturing and production processes, process flow, and product testing requirements.

Mansioni

• Analyze quality processes, procedures and documentations against ISO standards and 21 CFR 820 regulations to ensure compliance and adherence.
• Update corrective actions, including identification of issues, development of corrective action plans, implementation, and follow-up verification.
• Manage and support the complaint handling process, including complaint intake, investigation, documentation, and resolution.
• Validate and improve procedures and work instructions to ensure they are clear, accurate, and aligned with regulatory and quality system requirements.
• Maintain and revise documentation control processes to ensure controlled, compliant, and up-to-date quality documentation.
• Initiate, review, and manage engineering change orders to ensure changes are properly evaluated, documented, and implemented in production and quality systems.
• Collaborate with cross-functional, interdisciplinary teams to address quality issues, optimize process flow, and support continuous improvement initiatives.
• Coordinate with external auditors, providing necessary documentation, explanations, and follow-up actions related to quality systems and regulatory compliance.
• Prepare clear, accurate technical reports and investigation summaries documenting findings, conclusions, and recommended actions.

Conoscenze

QA / Documentation Control

CAPA processes

Technical writing

Regulatory compliance

Cross-functional collaboration

Attention to detail

Descrizione del lavoro

The Quality Assurance Specialist serves as a technical quality resource across Operations and Quality Assurance, analyzing and updating existing documents against ISO standards and 21 CFR 820 requirements to ensure regulatory compliance. This role provides solutions to quality and compliance issues, supports manufacturing activities, and contributes to the continuous improvement of the quality management system within a medical device production environment.

Responsibilities

• Analyze quality processes, procedures and documentations against ISO standards and 21 CFR 820 regulations to ensure compliance and adherence.
• Update corrective actions, including identification of issues, development of corrective action plans, implementation, and follow-up verification.
• Manage and support the complaint handling process, including complaint intake, investigation, documentation, and resolution.
• Validate and improve procedures and work instructions to ensure they are clear, accurate, and aligned with regulatory and quality system requirements.
• Maintain and revise documentation control processes to ensure controlled, compliant, and up-to-date quality documentation.
• Initiate, review, and manage engineering change orders to ensure changes are properly evaluated, documented, and implemented in production and quality systems.
• Collaborate with cross-functional, interdisciplinary teams to address quality issues, optimize process flow, and support continuous improvement initiatives.
• Coordinate with external auditors, providing necessary documentation, explanations, and follow-up actions related to quality systems and regulatory compliance.
• Prepare clear, accurate technical reports and investigation summaries documenting findings, conclusions, and recommended actions.

Essential Skills

• Quality assurance or Documentation Control preferably 13 years in quality assurance or operations.
• Background in QA, with additional QC experience considered beneficial.
• Experience in medical products, medical device, pharmaceutical, or disposable product manufacturing environments a plus.
• Practical experience with Corrective Action and Preventive Action (CAPA) processes, including corrective action plans and follow-through.
• Technical writing skills for clear, structured reporting of investigations and preparation of compliance documentation.
• Ability to validate and refine work instructions and procedures to ensure clarity and regulatory alignment.
• Understanding of manufacturing and production processes, process flow, and product testing requirements.

Additional Skills & Qualifications

• Experience in medical device or disposable product manufacturing is preferred.
• Comfort working with external vendors, customers, and auditors in a professional and collaborative manner.
• Ability to work effectively as part of an interdisciplinary team and support ongoing product manufacturing.
• Strong communication skills, with the ability to provide technical consultation in a positive, supportive manner.
• Attention to detail and strong documentation practices to maintain accurate quality records.

Work Environment

This role operates in a medical device manufacturing environment and involves close collaboration with cross-functional internal teams in Operations, Quality Assurance, and manufacturing, as well as interaction with external vendors, customers, and auditors. The environment emphasizes regulatory compliance, technical rigor, and a culture of continuous improvement and teamwork.

Job Type & Location

This is a Contract position based out of Haltom City, TX.

Pay and Benefits

The pay range for this position is $24.00 - $28.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your jobclassification and length of employment. Benefits are subject to change and may besubject to specific elections, plan, or program terms. If eligible, the benefitsavailable for this temporary role may include the following:Medical, dental & visionCritical Illness, Accident, and Hospital401(k) Retirement Plan Pre-tax and Roth post-tax contributions availableLife Insurance (Voluntary Life & AD&D for the employee and dependents)Short and long-term disabilityHealth Spending Account (HSA)Transportation benefitsEmployee Assistance ProgramTime Off/Leave (PTO, Vacation or Sick Leave)

Job Type & Location

This is a Contract position based out of Haltom City, TX.

Application Deadline

This position is anticipated to close on Nov 24, 2026.

Workplace Type

This is a fully onsite position in Haltom City,TX.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.